AMTRION GMBH (formerly Haseke & Kroemker)

FDA Device Registration & Listing · Porta Westfalica North Rhine-Westphalia, DE · Registration 3005285078

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005285078
FEI Number
3005285078
Entity Name
AMTRION GMBH (formerly Haseke & Kroemker)
City/State/Country
Porta Westfalica North Rhine-Westphalia, DE
Establishment Address
Sandtrift 1, Porta Westfalica North Rhine-Westphalia 32457, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Amtrion GmbH (Owner Number: 10082386)
Owner / Operator Contact Address
Sandtrift 1, Porta Westfalica, DE-NW 32457, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Ultra Sonic - USA Claws SKYDOQ Spring Arm5 SKYDOQ Wall Mount FA24 SKYDOQ Central Axis SKYDOQ Spring Arm24 SKYDOQ Monitor Carrier for Spring Arms

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-09-28
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2026-03-12
FQO Table, Operating-Room, Ac-Powered General, Plastic Surgery Class 1 878.4960 2024-09-23

Official Correspondent

Leonhard Gellermann

US Agent Details

Stephen Gorski Business: Imagenix, Inc. Email: stephengorski@me.com Phone: (414) 7374596

Related Public Records

Same Entity

Amtrion GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K163485 Adherium (Nz), Ltd. SmartTouch 2017-08-30
K781467 Travenol Laboratories, S.A. U-FLOAT VALVE 2D9023 1978-09-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2024 Getinge Usa Sales Inc 1
Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005285078. Last updated year: 2026. Please use registration number 3005285078 when referencing this establishment in official correspondence.
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